๐๏ธ Verified NIH Record โข Updated 2026-08-13
Investigations of Reproductive Cancers in Women (NCT06527157)
๐ข Recruiting Interventional Protocol ๐ Observational Clinical Research Sponsor: PinkDx, Inc.
๐ฉบ Plain-English Summary (8th-Grade Level)
The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).
Location: University of Alabama, Birmingham โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.
- Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.
- Women who have had a hysterectomy.
- Women with a known history of endometrial cancer or uterine sarcoma.
- Women who have received prior treatment for endometrial cancer.
- Inability or unwillingness to sign informed consent.
- Clinical suspicion of pregnancy.
- Women who have used a tampon within 7 days of sample collection.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (16 Sites)
- University of Alabama, Birmingham โ Birmingham, Alabama
- Sutter Health โ San Carlos, California
- Advent Health Orlando โ Orlando, Florida
- Ob-Gyne Associates of Lake Forest, Ltd โ Lake Forest, Illinois
- Indiana University, Eskenazi Health โ Indianapolis, Indiana
- Mayo Clinic โ Rochester, Minnesota
- Washington University School of Medicine โ St Louis, Missouri
- Columbia University โ New York, New York
- Summa Health โ Akron, Ohio
- The Ohio State University โ Columbus, Ohio
- Avera Research Institute โ Sioux Falls, South Dakota
- University of Tennessee Health Science Center โ Memphis, Tennessee
- Meharry Medical College โ Nashville, Tennessee
- Baylor College of Medicine/Texas Children's Hospital โ Houston, Texas
- Houston Methodist โ Houston, Texas
- University of Texas Health Science Center at San Antonio โ San Antonio, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.